Biosimilars Policy

Arthritis Consumer Experts (ACE) has been learning about biosimilars since 2009 and has become a national thought leader, conducting biosimilar workshops and sharing education with multi-stakeholder groups across Canada. The ACE biosimilars dialogue across Canada has included patients, healthcare professionals and policy decision makers in government and private health insurance.

Current policy decisions on biosimilars

Biosimilars offer patients and physicians another choice in the treatment of inflammatory arthritis.

Provincial formularies and private health insurers have begun providing reimbursement for the first biosimilar approved in Canada for the treatment of inflammatory forms of arthritis. Both provincial and private payers are considering biosimilars as a key element in their mandates to list cost-effective medication treatment that is clinically meaningful to patients and contributes to long-term cost reductions and drug plan sustainability.

Through the pan-Canadian Pharmaceutical Alliance (pCPA), provincial and territorial public drug plans negotiated a significantly lower transparent list price for Infliximab (Inflectra); according to the pCPA this will enable savings for both public and private payers that can be reinvested into other treatments or therapies. In April 2016, the pCPA released its First Principles for Subsequent Entry Biologics to guide negotiations and inform expectations of biosimilar manufacturers, as the pCPA works towards establishment of a biosimilars policy framework.

Determining the value to patients and the health care system
Tracking the efficacy, safety and value to patients and the health care system of both originator biologics and their biosimilars is important. Patients and their physicians rely on this "real world data" when they are making treatment decisions.

As biosimilars research data continues to be published and policies regulating them evolve, ACE is meeting with public formulary and private payer decision makers to provide its membership’s views on the placement of biosimilars in therapy.

ACE is advocating to provincial governments to reinvest drug plan savings from biosimilar listings back to drug plan budgets by listing new medicines coming into the marketplace to address unmet needs.

The first biosimilars in Canada

In 2015, the first biosimilar in Canada approved for inflammatory arthritis was infliximab (Inflectra). It was launched to treat severe rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). In 2016, infliximab (Inflectra) is being added to many provincial drug plans and private health insurance plans for the treatment of these diseases.

Infliximab (Inflectra) is a biosimilar version of infliximab based upon the originator biologic infliximab (Remicade). It was issued a Notice of Compliance (or “approved”) by Health Canada and recommended for listing on provincial formularies by the national Common Drug Review.

Health Canada has stated that originator biologics and biosimilars are not declared to be pharmaceutically or therapeutically equivalent. While there are concerns that biosimilars may have unique efficacy, immunogenicity, and safety profiles that are distinct from their originator biologics, the approval of biosimilars in Canada relies on the demonstration that these measures are equal between them. This is demonstrated through clinical (equivalence) trials in at least one disease indication, such as rheumatoid arthritis."

Health Canada does not support automatic substitution and does not recommend interchangeability of the biosimilar and the originator biologic; however, the decision to substitute one for the other is a provincial or private health insurer’s decision.

For information on Health Canada’s decision, please see the Summary Basis of Decision for infliximab (Inflectra) available at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_...

Additional information may be found in the Inflectra Product Monograph, approved by Health Canada and available here.

https://www.cadth.ca/media/cdr/monograph/Inflectra_Product%20Monograph.pdf

For Common Drug Review’s review and recommendation, please see https://www.cadth.ca/sites/default/files/cdr/complete/cdr_complete_SE038...

The second biosimilar in Canada approved for inflammatory arthritis is Brenzys (etanercept). It is a biosimilar version of etanercept based upon the reference product Enbrel (etanercept). It was issued a Notice of Compliance by Health Canada on August 31, 2016 for the treatment of patients with rheumatoid arthritis and ankylosing spondylitis.

For information on Health Canada's decision, please see the Summary of Basis of Decision for etanercept (Brenzys) availble at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-brenz...

Biosimilars Policy FAQs

Are patients taking infliximab (Remicade) and currently reimbursed by a provincial formulary or private drug plan required to transition to infliximab (Inflectra)?

Health Canada recommends that physicians make well-informed choices when considering interchanging therapies. Currently, provincial and private drug plans are not mandating policy transition between a patient’s current biologic to an approved biosimilar.

In terms of “policy transitions,” (sometimes referred to as “switching”) the following medical associations in the North American arthritis community have issued positions on this subject:

- Canadian Rheumatology Association (CRA) – The CRA position states that there should not be interchangeability between a biosimilar and an innovator molecule.  Further, there should not be substitutions from one biologic to another, including biosimilar and innovator molecules.

 

- American College of Rheumatology (ACR) – One of the ACR’s key principles in its guidelines document (which was published before biosimilars had been approved in the U.S.) is that “if a RA patient has low RA disease activity or is in clinical remission, switching from one therapy to another should be considered only at the discretion of the treating physician in consultation with the patient. Arbitrary switching between RA therapies based only on a payer/insurance company policy is not recommended.”

ACE defines the term “transition” in two ways:

Policy Transitions

Policy transitions (also referred to as non-medical switching) necessitate patients to change their medicine of choice to another, typically less expensive, medicine, not for a medical reason.

Medical Transitions

In the case of a patient not doing well on their current originator biologic or biosimilar of choice, a transition to another originator biologic or biosimilar, or other non-biologic medicine, with a different molecular action is then considered by the patient and their rheumatologist. Transitioning when medically required is important to achieving the best disease control and outcomes.

What other diseases has infliximab (Inflectra) been approved for?

On June 14, 2016, infliximab (Inflectra) was approved by Health Canada for three additional indications: Crohn's disease, fistulising Crohn’s disease and ulcerative colitis.

What is the current funding status of infliximab (Inflectra) with Canadian private health insurers?

All private health insurers have listed Infliximab (Inflectra).

Green Shield Canada and a number of other small insurers have criteria that mandates patients newly prescribed infliximab to receive infliximab (Inflectra) in place of infliximab (Remicade) for rheumatoid arthritis, psoriatic arthritis, and ankylosing arthritis.

In particular, Green Shield’s policy is to:

- Preferentially list biosimilars on its formularies

- Cover originator products in exceptional circumstances only

- Keep patients on originator biologics if they started treatment prior to its policy statement

As of May 1, 2016, Remicade (infliximab) remains in first tier for all indications with the major insurers (e.g. Sun Life, Great West Life, Manulife).

Have you been affected by new biosimilars policy?

Provincial formularies and private health insurers have begun providing reimbursement for the first biosimilar approved in Canada. Have you had experience gaining reimbursement for a biosimilar prescription with a provincial or private health insurance formulary?

Current funding status of infliximab (Inflectra) with provincial formularies

Infliximab (Inflectra) has been listed in a number of provinces across Canada. Here is a summary of the reimbursement criteria in those provinces.

Quebec

Effective February, 2015, RAMQ covers infliximab (Inflectra) and infliximab (Remicade) for the treatment of eligible rheumatology and dermatology indications – rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis, plaque psoriasis – at a Maximum Allowable Cost, whereby physicians and patients may choose infliximab (Inflectra) or infliximab (Remicade) and the province obtains equal cost savings.

ACE is interested in hearing from patients about their experience with biosimilars in Quebec. Do you have biosimilar news to share?

British Columbia

Effective February 19, 2016, BC PharmaCare covers infliximab (Inflectra) for the treatment of eligible rheumatology and dermatology indications – rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis, plaque psoriasis - according to existing Limited Coverage criteria. All Special Authority (SA) requests for coverage of infliximab for infliximab-naïve patients requiring the medication for rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis and plaque psoriasis will be reimbursed for the infliximab (Inflectra) brand of infliximab only. Patients whose initial Special Authority was received before February 19, 2016, will be eligible for continued coverage of infliximab (Remicade).

Coverage of these drugs is subject to the rules of a patient's BC PharmaCare plan, including any annual deductible requirement. Retroactive coverage cannot be provided for prescriptions filled before Special Authority approval is in place. 

ACE is interested in hearing from BC patients about their experience with biosimilars. Do you have biosimilars news to share?

Ontario

Effective February 25 2016, infliximab (Inflectra) was added to the Ontario Drug Benefit (ODB) Formulary as a Limited Use (LU) benefit for the treatment of severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Only infliximab (Inflectra) for patients newly started on infliximab will be reimbursed by the province.

Patients who have an existing Exceptional Access Program (EAP) approval for infliximab (Remicade) can continue to receive infliximab (Remicade) for the duration of the EAP approval period. The ministry will also consider EAP renewal requests for infliximab (Remicade) for patients with existing EAP approvals.

The Limited Use (LU) criteria for infliximab (Inflectra) will apply to both new and existing patients with severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Claims for infliximab (Inflectra) will be reimbursed under the ODB program when prescribed in accordance with the LU criteria and accompanied by a valid, fully completed prescription with the appropriate LU documentation (RFU code).

Limited Use drugs are those drugs recommended by Ontario’s external expert drug advisory committee as having value in specific circumstances, although they may not be considered for general listing in the public formulary. A LU listing allows a specialty physician, such as a rheumatologist or dermatologist, to write the prescription for infliximab (Inflectra) without having to fill out additional forms justifying the need for the prescription. A LU listing may save days or weeks of time that occurs in the Exceptional Access Program review process and allows the patient go directly to the pharmacy to have the prescription filled.

In March 2016, the Ontario Rheumatologist Association published this communication on their website, clarifying some special populations where patients newly prescribed infliximab (Remicade) will be eligible for funding under EAP in Ontario:

- Sub-populations: New starts for juvenile idiopathic arthritis (JIA) – all subtypes and both adult and pediatric Uveitis (non-infectious ocular inflammatory disease) who meet EAP criteria will continue to receive infliximab (Remicade).

- A patient who is on infliximab (Remicade) prior to February 25, 2016 and who meet EAP criteria will continue with infliximab (Remicade). At this time there is no mandatory switching.

- Clients age <65 previously on infliximab (Remicade) paid for by private insurance who turn 65 and meet EAP criteria are eligible to continue with infliximab (Remicade), without a mandatory switch to infliximab (Inflectra).

ACE is interested in hearing from patients about their experience with biosimilars in Ontario. Do you have biosimilar news to share?

Alberta

Effective April 1, 2016, all new Special Authorization requests for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis for infliximab naive patients are assessed for coverage with infliximab (Inflectra). 

Infliximab (Remicade) will not be approved for patients, with ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis, newly prescribed infliximab; however, coverage for infliximab (Remicade) will continue for patients who are currently well maintained on infliximab (Remicade) and are considered a 'responder' as defined in criteria. 

ACE is interested in hearing from Albertan patients about their experience with biosimilars. Do you have biosimilar news to share?

Manitoba

Effective April 18 2016, infliximab (Inflectra) was added to the Manitoba Drug Benefits and Interchangeability Formulary for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

All Special Authority (SA) requests for coverage of infliximab for infliximab-naïve patients requiring the drug for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis will be approved for the infliximab (Inflectra) brand of infliximab only. Patients whose initial Special Authority was received before April 18, 2016, will be eligible for continued coverage of infliximab (Remicade).

ACE is interested in hearing from patients about their experience with biosimilars in Manitoba. Do you have biosimilar news to share?

Saskatchewan

Effective May 1, 2016, under the Non-Interchangeable Exception Drug Status Program (EDS), infliximab (Inflectra) is authorized for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis. The listing allows patients, with ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis, newly prescribed infliximab (“new starts”) to start with Infliximab (Inflectra) or infliximab (Remicade).

ACE is interested in hearing from Saskatchewan patients about their experience with biosimilars. Do you have biosimilar news to share?

Nova Scotia

Effective June 1, 2016, under the Exception Status Drug program, infliximab (Inflectra) is authorized for the treatment of ankylosing spondylitis, plaque psoriasis, or rheumatoid arthritis.

For infliximab-naïve patients whose infliximab therapy is initiated after June 1, 2016, infliximab (Inflectra) will be the product approved for rheumatoid arthritis and ankylosing spondylitis.

ACE is interested in hearing from Nova Scotia patients about their experience with biosimilars. Do you have biosimilar news to share?

New Brunswick

Effective June 1, 2016, under the New Brunswick Drug Plans Special Authorization Program, infliximab (Inflectra) will be approved for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

Please note that all Special Authorization (SA) requests for reimbursement of infliximab for infliximab-naïve patients for ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis (RA) will be approved for the Inflectra brand of infliximab only. Patients who received SA approval for the Remicade brand of infliximab before June 1, 2016 will continue to have this brand covered. They will also be eligible for reimbursement of infliximab (Inflectra).

ACE is interested in hearing from patients about their experience with biosimilars in New Brunswick. Do you have biosimilar news to share?

Prince Edward Island

Effective June 27, 2016, under the High Cost Drug Program and Catastrophic Drug Program, infliximab (Inflectra) will be the product approved for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

For infliximab-naïve patients effective June 27, 2016 or later, infliximab (Inflectra) will be the product approved for the ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis. Naïve patients are defined as those not on maintenance infliximab therapy (including those receiving induction therapy) as of the effective date of coverage on PEI (June 27, 2016).

ACE is interested in hearing from patients about their experience with biosimilars in PEI. Do you have biosimilar news to share?